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OpenTrials
Completed

NCT Number: NCT06379568

Risk of Aspergillus Infection in Patients With Chronic Lung Disease

Large doses of systemic corticosteroids ,severe lung tissue damage and longer COPD diagnosis may increase the risk of IPA in patients with chronic structural lung disease. By comparing the risk factors of aspergillus colonization group and aspergillus infection group, the main risk factors of aspergillus pneumonia were determined.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

About this study

Patients with chronic lung disease were identified as positive for Aspergillus fumigatus through sputum microscopy. According to diagnostic criteria, patients diagnosed with IPA and CPA and were assigned to the Aspergillosis pneumonia group, while the remaining patients were included in the Aspergillus colonization group. Then,Risk factors for aspergillus pneumonia, invasive pulmonary aspergillus disease, and chronic pulmonary aspergillus disease, such as the use of high-dose corticosteroids, inhaled corticosteroids, and the extent of damage to basic lung structures, were identified by comparing the aspergillus colonization group with the aspergillus infection group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age : at least 18 years old ;
  • Imageological examination : Patients who complete high-resolution computed tomography (HRCT) images of the chest;
  • Serological examination : Patients who complete serological test results, including serum aspergillus specific IgG antibody, serum aspergillus IgM antibody and GM antigen detection.

Exclusion criteria

  • immunodeficiency conditions : Patients diagnosed with HIV infection, hematological malignancies, and autoimmune diseases.
  • Critically ill patients : Those who require mechanical ventilation in the ICU and have established various types of cardiopulmonary bypass.
  • Inadequate Clinical Data: Inability to provide reliable diagnostic measurements or insufficient clinical information.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Descriptive statistical index

    Time frame: Information was collected on the day of admission

    Summarize participant characteristics using means and standard deviations for continuous variables and frequencies for categorical variables

  2. Independent risk factor for aspergillus pneumonia

    Time frame: Statistical analysis was carried out after data collection within one month

    Independent risk factors for aspergillus infection were determined by multivariate logistic regression analysis.

  3. The area under ROC curve of risk factors for aspergillus pneumonia

    Time frame: Statistical analysis was carried out after data collection within two month

    The area under ROC curve (AUC) was used to evaluate the classification effect of the binary classification model among Aspergillus pneumonia group, IPA group and CPA group

Secondary outcomes

  1. Threshold analysis of aspergillus pneumonia

    Time frame: Statistical analysis was carried out after data collection within two month

    Specific cut-off values for Aspergillus specific IgG antibody × lung structural injury image score was determined to maximize diagnostic accuracy, focusing on sensitivity, specificity, and Youden index.

Sponsors and collaborators

Lead sponsor

Lin Chen

Other

Registry information

Official study title

Risk of Aspergillus Infection in Patients With Chronic Structural Lung Disease

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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